Single use, prepackaged vaccinator



March 14, 1961 M. S. COOPER SINGLE USE, PREPACKAGED VACCINATOR Filed May 10, 1960 IN VEN TOR. MHZ/P11) 5AM 600/25? BY M 4441mm United States Patent SINGLE USE, PREPACKAGED VACCINATOR Murray Sam Cooper, Dumont, NJ., assignor to American Cyanamid Company, New York, N.Y., a corporation of Maine Filed May 10, 1960, Ser. No. 28,109

2 Claims. (Cl. 206-632) punctures the plastic bubble and carries on its prongs the biologically-active fluid; the plastic bubble being attached to a backing strip and being surrounded by an absorbent material.

Intracutaneous injections are used to vaccinate against diseases such as smallpox and diagnostically to test for tuberculosis and for the diagnosis of histoplasmosis, blastomycosis, coccidimycosis, cryptococcosis, sporotrichosis, and for allergic reactions towards tetanus, penicillin, horse serum or any of the other group of materials, including proteins, towards which allergic sensitivities may occur.

Sealed envelopes containing a biologic fluid and an injection device adapted to penetrate the envelope and the epidermis of a test subject have been disclosed previously, including the disclosure in United States Patent. No. 2,893,392, A. R. Wagner and M. S. Cooper, Article of Manufacture for Intracutaneous Injections, July 7, 1959. The present prepackaged vaccinator is an improvement in which the plastic bubble containing the biologicalliquid is united, preferably adhesively, to a backing strip and is surrounded by an absorbent material, such as blotting paper. The plastic bubble is protected by apertured spar ers and is enclosed in a sterile enclosure conveniently of plastic sheets, the entire bubble assembly being externally sterile so that the sterile enclosure may be opened and the biological liquid administered by pressing the bubble against the skin of the subject to cause the prongs of the injector plate to penetrate both the plastic bubble and the skin. The skin must be cleansed in accordance with the usual procedures, but the external surface of the plastic bubble and its contents are ready for use without additional treatment or operations.

The immediate and ready availability of the prepackaged vaccinator enable an unskilled assistant to vaccinate or test large numbers of subjects rapidly, economically, eificiently, 'and with a risk of secondary infection.

The blotting material which surrounds the plastic bubble may be of blotting paper or absorbent gauze, or other liquid-absorbing material. By absorbing any biological liquid which escapes from the plastic bubble such biological liquid is prevented from coming in contact with the hands of the administrator. This protects the hands of the administrator, which could become sensitive towards particular biological liquids, and also reduces the possibility of the administrator inadvertently transferring a biological liquid which could otherwise escape onto the administrators hands and be transferred to a second patient, or a difierent area on the first patient.

In testing for allergies, it is quite common to simultaneously administer a number of possible allergens to different areas of the skin of a subject and, by reading 7 Patented Mar. 14, 1961 the elfect of each on the skin, determine which of the allergens elicits a response on a specific subject. Inasmuch as the reading is based on a local area of reaction, it is essential that the test liquid for each area be confined to that area. If a biological liquid is allowed to escape and come in contact with the fingers of an administrator, biologically-active material can be inadvertently transferred; thus compromising the reliability of the results.

Other uses and advantages of the present prepackaged vaccinator are apparent to those skilled in the art from the descriptions of certain embodiments of the present invention which are shown in the accompanying drawings.

Figure 1 is a pictorial view of an assembled prepackaged vaocinator.

Figure 2 is a cross section of an assembled prepackaged vaccinator.

Figure 3 is a pictorial, in partial section, of a modification using an internally pronged injector in the bubble.

Figure 4 is a pictorial, in partial section, of a multiple pronged injector in a bubble.

Referring more particularly to the cross section of the embodiment shown in Figure 2, the prepackaged vaccinator comprises an injector plate 11 which conveniently is a square plate having a cut-out hole 13, to reduce its weight and permit freer circulation of the liquid bubble contents, and which square plate has thereon a plurality of pron-gs 14. As shown in Figure 2, these prongs are externally formed on the square plate with two prongs adjacent each of four corners, which prongs are bent at an angle of with the square plate, thus bringing the two prongs at a corner into juxtaposition with a gap 16 between each pair of prongs. It is preferred that all of the points 15 of the prongs be in approximately the same plane with the prongs having the same length. The gap between the prongs, by capillarity, attracts and holds the biological liquid to be administered. The injector plate is enclosed in a plastic bubble 17 comprising a rounded bubble cover 18 peripherally sealed to a bubble fiat 19. The bubble cover and the bubble fiat may be adhesively sealed, but are more conveniently heat sealed to form a hermetically sealed enclosure.

The bubble is fastened to a backing strip 20 which conveniently is a square of cloth to which the bubble is united with an adhesive 21. Ordinary adhesive tape with a moisture-proof backing gives good results. Surrounding the plastic bubble and also adherent to the backing strip is an absorbent material 22 which conveniently is blotting paper. Other absorbent materials, such as gauze and cotton, may be used. The absorbent material should have sufficient absorptive capacity to ensure that the liquid contents of the bubble are absorbed rather than flowing from under the backing strip on administration.

In the final assembly, the plastic bubble is protected by apertured spacers 23 which are in contact with the absorbent material and surround the plastic bubble with the aperture of suflicient size to contain the plastic bubble. One thicker or a group of thinner spacers may be used. Preferably, the spacers are of cardboard stacked to sufficient thickness to protect the bubble containing the injector plate from pressure. The backing strip with the bubble and the apertured spacers is enclosed in a sterile enclosure 27 which consists of an upper plastic sheet 24 and a lower plastic sheet 25, which are connected to each other by an edge seal 26.

Inside the plastic bubble is the biological liquid 28 above referred to. The biological liquid may be any of a wide variety of biological agents, the selection of which is within the skill of the art.

It is preferred that the plastic sheets 24 and 25 be such that the final assembly may be sterilized by passing carbon such as the Freons, to reduce the explosive hazard, throughthe plastic sheets to sterilize the inside of the sterile enclosure. If the biological liquid sensitive to such agent, the bubble should be impermeableto the gaseous sterilizing agent during the sterilizing cycle. An internal bubble of a polymer of ethylene glycol and terephthalic acid (Mylar) is satisfactory. Other plastics may be used, including polyethylene films, rubber hydrochloride, nylon, etc. A thickness of at least 0.0005 may be used; a. thickness of more than 0.005 can become difficult to penetrate during use.

The outer envelope forming the sterile enclosure can be of cellophane, polyethylene, etc. i

If other sterilizing conditions are used, such as radiation or heat, the plastic films may be modified accordingly. Usually, it is most convenient to sterilize the plastic from which the plastic bubble is formed using a sterile bubble cover and a sterile bubble flat which are filled with the biological liquid and the sterile injector plate aseptically. A clean but not sterile assembly system may be used where the biological liquid is sufficiently resistant to stand a gaseous heat or radiation sterilizing cycle, with sterilization after assembly. Such method of assembly is largely determined by the characteristics of the specific biological liquid being administered. The inside of the bubble should be sterile, except for any desired biological activity. i

The exact size and shape of the bubble and the quantity of biological liquid and its characteristics are selected to meet the particular situation. Usually, a couple of drops of biological liquid with an injector plate A of an inch on a side gives rapid and reliable results. Larger or smaller embodiments may be used depending on the strength of a particular biological liquid, the dosage required, and the thickness of the skin ofthe proposed subject. The prepackaged vaccinator is frequentlyused on human subjects, but can be used on animals.

A prong length of 1 to 10 millimeters is usually suflicient for such uses. A prong length of 2 to 5 millimeters is especially useful on humans.

In use, the outer sterile enclosure is broached and the plastic bubble sterilely removed, the spacer discarded, the bubble cover placed against a clean skin surface, and pressure applied through the backing strip which causes the points of the prongs to penetrate the bubble cover and the skin of the subject, carrying with them the dosage of biological liquid.

A separate modification of the plastic bubble is shown in Figure 3 in which four prongs are formed by being cut out internally of the injector plate so that the four prongs are adjacent to a rectangular cut out hole.

A third embodiment is shown in Figure 4, in which an injector plate is used, having a plurality 0t prongs punched from the plate.

These and other modifications are apparent to those skilled in the art, and come within the scope of the present invention which is set forth in the appended claims.

1 claim:

lJA-singIe use, prepackaged vaccinator comprising:

an 'injecto'r plate having pointed, penetrating prongs, a penetrable plastic bubble enclosing said plate, a biologi cal liquid in said bubble with said injector plate, a backing strip to which the bubble is attached, an absorbent material surrounding the plastic bubble, and also attached to the backing strip, at least one apertured spacer surrounding the plastic bubble, and a sterile enclosure inwhich the bubble, backing strip, absorbent material and spacer are sterilely protected from external contamination and from which the bubble and its contents may be sterilely removed. 2. A single use, prepackaged vaccinator comprising: an injector plate having pointed, penetrating prongs, a penetrable plastic bubble enclosing said plate, a biological liquid in said'bubble with said injector plate, a backing strip to which the bubble is adhesively united, an absorbent material surrounding the plastic bubble and adhesively united to the backing strip, at least one aper tured spaced surrounding the plastic bubble, and a sterile enclosure which the bubble, backing strip, absorbent material and spacer are sterilely protected from external contamination-and from which the bubble and its contents may he sterilely removed.

No r e en es i e 

